QA Associate I - Sun to Thurs afternoon shift

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

s part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

Work Shift:

Sunday through Thursday

3:30 PM – 11:30 PM (Afternoon Shift)

18-month fixed-term contract

REQUIRED QUALIFICATIONS

Education:

Bachelor's Degree required, no prior experience required.

Preferred: Science-related degree.

Experience:

• Production/packaging and GMP experience strongly preferred.
• Documentation review experience preferred.
• Experience in pharmaceutical, medical device or regulated industry preferred.
• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field.
• GMP knowledge in pharmaceutical manufacturing/packaging.
• Additional certifications in Quality Systems or GMP preferred.
• Strong knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements.
• Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA

Knowledge, Skills and Abilities: 

• Proficiency in quality management software systems (TrackWise, SAP, etc.)
• Demonstrated ability to perform detailed documentation review and quality assessments.
• Strong communication and interpersonal skills.
• Comfortable interacting cross-functionally.
• Detail-oriented and capable of reviewing large volumes of documentation.
• Quick learner.
• Strong analytical and problem-solving skills for quality investigations and root cause analysis.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Experience conducting internal quality audits and supporting external regulatory audits.
• Proficient computer skills including Microsoft Office applications.
• Strong attention to detail and commitment to accuracy.
• Ability to prioritize and adapt in a changing environment.
• Experience with continuous improvement methodologies (Lean, Six Sigma) preferred.
• May require up to 10% travel.
• Must be able to work in controlled environments wearing required PPE.

Compensation

The salary range estimated for this position based in Ontario is $50,000.00–$55,000.00.